With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner. Concurrently, the US Senate is working to permanently...
FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
Uk.reuters.com just released an article about the lackluster number of approved drugs by FDA in 2013. In 2013 only 27 were approved vs. 39 in 2012, which was the most since 1997. FDA attributed the large decrease to fewer applications in 2013 which was down from 41 to...
The healthcare industry, medical research and drug approval process are projected to be greatly affected by the federal budget cuts scheduled for March 1, according to a recent article on mondernhealthcare.com. The Budget Control Act of 2011, originally scheduled to...
The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers...
